Comparing two treatments for urinary retention in men with BPH
Prostatic Urethral Lift Versus Transurethral Resection of Prostate in Benign Prostatic Hyperplasia Patients With Urinary Retention
This study is testing whether a new procedure called prostatic urethral lift works better than the traditional surgery for helping men with urinary retention caused by an enlarged prostate.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 40 Years and up |
| Sex | Male |
| Sponsor | Queen Mary Hospital, Hong Kong Academic / other |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT06037356 on ClinicalTrials.gov |
What this trial studies
This study is a prospective, randomized controlled trial that compares the effectiveness of prostatic urethral lift (PUL) versus transurethral resection of prostate (TURP) in male patients suffering from benign prostate hyperplasia (BPH) with urinary retention. The primary goal is to evaluate the rates of catheter-free recovery between the two procedures. Secondary objectives include assessing complication rates, cost-effectiveness, patient satisfaction, symptom scores, quality of life, and urodynamic parameters. Eligible participants will undergo a series of assessments before being randomized to one of the two treatment groups, with follow-up evaluations scheduled over five years.
Who should consider this trial
Good fit: Ideal candidates for this study are male patients over 40 years old who are experiencing urinary retention and have failed a trial without a catheter.
Not a fit: Patients who may not benefit from this study include those with active urinary tract infections, previous surgical treatments for BPH, or other specific urinary tract conditions.
Why it matters
Potential benefit: If successful, this study could provide a less invasive treatment option for men with BPH and urinary retention, potentially leading to improved recovery and quality of life.
How similar studies have performed: Other studies have shown promising results with similar approaches, indicating that this comparison could yield valuable insights into treatment options for BPH.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male patients * age \>40 years old * urinary retention who failed trial without catheter Exclusion Criteria: * Inability to provide consent OR no guardians or relatives to help provide consent on patient's behalf * Active urinary tract infection * Previous surgical treatment for benign prostatic hyperplasia (i.e., TURP, prostatic urethral lift, etc.) * Bladder stones * Urethral strictures or bladder neck contractures * Prostate size \>100mL * Solely obstructing median lobe * Urinary retention not due to obstruction (i.e., Bladder outflow obstruction index \<20 on urodynamic studies) * Poor detrusor contractility (maximum detrusor pressure \<20cmH2O during voiding phase) * Anticoagulant or antiplatelet agents that cannot be stopped
Where this trial is running
Hong Kong
- Queen Mary Hospital — Hong Kong, China (Recruiting)
Study contacts
- Principal investigator: Brian SH Ho, MBBS — Queen Mary Hospital, Hong Kong
- Study coordinator: Brian SH Ho, MBBS
- Email: hobrian@hku.hk
- Phone: (852)2255-3023
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.